FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2781354
·
Received October 10, 2012
Report
- Report Number
- 1720753-2012-08162
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 10, 2012
- Report Date
- October 10, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED A GENERATOR ERROR. THIS MESSAGE APPEARS WHEN THE SYSTEM DETECTS AN ERROR IN ANY OF THE REGISTERS ASSOCIATED WITH THE HIGH VOLTAGE GENERATOR. THE SYSTEM SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |